Central Challenges Facing the National Clinical Research Enterprise

Abstract

REAKTHROUGHS IN BASIC BIO-medical sciences, including human genomics, stem cell biology, biomedical engineering, molecular biology, and immunology, over the past 5 decades have provided an unprecedented supply of information for improving human health. This revolutionary progress in basic science would not have happened without the public's long-term investment in and steadfast commitment to basic biomedical research. Translating the information gained through these basic discoveries into knowledge that will affect clinical practice and, ultimately, human health requires clinical research involving human subjects and human populations, as well as devel-opment of improved health services based on that research. This next scientific frontier deserves a correspond-

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

“…27,28 In addition, the Institute of Medicine recommends basing treatment decisions on post-marketing studies tracking drug benefits and harms after FDA approval. [29][30][31] Thus, we conducted a systematic literature review of the comparative effectiveness and tolerability of the available preventive medications for episodic migraine in adults in outpatient settings to inform treatment and policy decisions (CRD42012001918). 32,33 The topic, research questions, and eligible interventions were nominated and posted for public comments on the Effective Healthcare website.…”

Modern Approaches to the Organization of Translational Research

“…As has been mentioned before, TR structure remains disputable. According to the earliest model by Sung et al, translation is a two-phase process: research proper (fundamental and clinical research) and organization (practical implementation) [14,15]. In other words, it is the route from bench to bedside (phase T1) and, subsequently, to the healthcare system in general (phase T2).…”

Uma geografia para a ciência faz diferença: um apelo da Saúde Pública

“…Esse processo, e seus desafios, estão mais bem descritos na literatura para o continuum da pesquisa clínica, a partir da bancada do laboratório até alcançar a prática clínica e as políticas de saúde 41 . Diferentes barreiras ou limites de enclausuramento do conhecimento são apontados e seus respectivos espaços de práticas institucionais, que vão desde as questões regulatórias, a incompletude das bases de dados, ausência de pesquisadores qualificados, as características dos sistemas de saúde, o alto custo das pesquisas, a desconfiança (ou confiança) da sociedade nos experts, dentre outros.…”